Summary
The goal of this tutorial is to show the process required to use the IRB: Consent to Participate in Research template located in REDCap. The Institutional Review Board approved this template (IRB), and it can be used to replace the paper version of the form for an electronic form. This form can be sent to participants as a survey to collect participants’ information and signatures electronically.
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Create a new REDCap project using a template
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Summary
The following document details how to set up an approved Institutional Review Board (IRB) electronic consent (e-consent) using the customized REDCap template, ‘IRB Consent Form: Participant Signature Required’. This template requires only the participant to sign the e-consent. This template should be used for online studies that do not involve any interaction with the participant.
The e-consent process works as follows:
- The e-consent is emailed to participants as a survey link.
- The e-consent will capture participant information and their electronic signature (e-signature).
- Participants will automatically receive a PDF copy of their signed e-consent via email.
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If an IRB protocol requires comprehension questions to be included in the e-consent, please contact redcap-help@utdallas.edu for assistance. REDCap e-consent projects with required comprehension questions must be set up so that the participant cannot submit and complete the e-consent without answering the comprehension questions correctly. This requires the use of external modules, custom CSS, and custom JS to function as expected. |
Enter project relevant information.
Enter the Project Title based on the IRB information.- log-in using your NetID and password.
- Create a new project by clicking +New Project.
- Enter the following project relevant information:
- Project Title
- Select Research from the
- Purpose of this
- project drop-down menu.
- Administrative details of the project such as the name of the P.I., email, IRB number,
Select ‘Use a template’ from the Start project from scratch or begin with template? options.
Select IRB: Consent to Participate in Research and click ‘Create Project.’
Modify the consent form text based on the project.
To modify the consent form text click on ‘Designer’ under Project Home and Design or click ‘Online Designer’ under Design your data collection instruments & enable your surveys.
Click on 'Choose action' to Rename the form as need it the click on the instrument to modify the text.
The consent temple contains 14 fields. Modify the text in red located in each field.
a. To access a field, click the edit pencil on the top section of the field.
b. Click the Full-Screen icon on the editor bars.
c. Replace red text with study specific language and change the text color to black.
d. Click Save and continue to the next field. Ensure all the red texts throughout the fields is replaced.
- etc.
- Specify the type of research that best applies.
- Under the section, Project creation option select Use a template to activate the list of project templates. Select the IRB Consent Form: Participant Signature Requiredand click Create Project.
Send Participant e-Consent Copy
This template is pre-configured to automatically send participants an email with a PDF copy of their signed consent. The body of the email may be configured. There are a few optional settings that can be configured.
- Navigate to the Online Designerand click the button Survey Settings for the instrument Consent to Participate in Research.
- The Send confirmation email? section settings are pre-configured so that when a participant submits their e-consent, they automatically receive an email with a PDF copy of the signed e-consent. You may modify the body of the email but DO NOT un-check the setting Include PDF of completed survey as attachment or change the Send confirmation email? Option to No.
- Scroll down to the bottom of the page and click the button Save Changes to commit any changes made to the email message.
Add Users and Define User Rights
based on Project RolesThe rights of each user accessing a project must be defined depending on the user’s profile and role in the study. It is recommended to check all access rights on a regular basis during the study.
Under ‘Applications’ on the right-hand side, select ‘User Rights’.
Add users to the project based on their roles.
a. Type the user’s NETID or name in the ‘Assign new user’ text box. A drop-down menu will provide options to select the correct user.
Please adviseAdd users to the project and define their access rights by assigning pre-defined user roles.
Note: It is recommended to review and update who has access to the project throughout the duration of the study.
- Navigate to User Rights.
- Type a user’s NetID or name in the Assign new user box. Select the correct user from the drop-down and click relative role to complete adding the user to the project.
Note: Users need to log in to REDCap at least once before they can be added to
- a project.
- See the image below to view the access rights which pertain to each role.
- Lab Manager Role
- : Have complete control and access to the project. They have access to identifiable information.
- Data Collector Role
- : Have the ability to create, view, and edit records. Data
- is de-identified when performing data
Change a REDCap Project Status to Production
This section will provide the necessary steps to change the project status from Development to Production. Completing these steps allows users to collect real study data. Additionally, it limits the risk of committing real-time changes to the project, which protects the data already collected.
- exports.
- exports.
Modify Consent Language
Modify the language in the consent so that it is specific to your project.
- Navigate to the Online Designer.
- (Optional) Click Choose action and select Rename to rename the form.
Click on the instrument name to modify the language in the consent.
- Edit a field by clicking the pencil icon.
Note: Text in red requires modification.
- Click the full-screen icon to widen the window to better edit the content. Be sure to click Save to commit any changes.
Move Project Status to Production
When the project is ready to begin collecting real data, and you have tested that the project logic behaves as expected, a user must request to move their project to 'Production' status. Moving the project to Production status requires the completion of seven steps located
on the
After completing each of the seven steps, click ‘I am done!’
After clicking on the last step ‘Move project to production’, the ‘Move Project to Production Status?’ dialog will open.
- Select ‘Keep ALL data saved so far’ or ‘Delete ALL data, calendar events, documents uploaded for records/responses, survey responses (if applicable), and any logging events pertaining to data collection.’
- If ‘Delete ALL data… ‘ is selected, a message box will open to confirm that you want to delete all the data.
- Click Yes, ‘Move Project to production’.
Complete the survey Move My Project to Production provided by the Office of Research Information Systems. The survey will guide you on moving your project to production more efficiently.
Upon submitting the survey, the REDCap Administrator will be emailed to start approving your study. After approval, your project will be moved to production.
For more information, please visit our website REDCap or send us an Email.Project Setup page. Visit our Project Status guide to move a project to production.(WIP) Note: Any changes made to a project in Production must be approved by a REDCap administrator to protect the integrity of any collected data.
| Note |
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If an IRB protocol requires comprehension questions to be included in the e-consent, please contact redcap-help@utdallas.edu for assistance. REDCap e-consent projects with required comprehension questions must be set up so that the participant cannot submit and complete the e-consent without answering the comprehension questions correctly. This requires the use of external modules, custom CSS, and custom JS to function as expected. |
Access Consent Copy
- Navigate to the Record Status Dashboard and select the Status icon for the desired record.
- Click Download PDF of instrument(s) and then select This survey with saved data to download a PDF copy of the signed e-consent.
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Need help? Contact: redcap-help@utdallas.edu Have IRB specific questions? Contact: irb@utdallas.edu |